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TOVIAZ®Highlights (fesoterodine fumarate)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TOVIAZ safely and effectively. See full prescribing information for TOVIAZ.

TOVIAZ® (fesoterodine fumarate) extended-release tablets, for oral use
Initial U.S. Approval: 2008

RECENT MAJOR CHANGES

Indications and Usage (1.1, 1.2)6/2021
Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5, 2.6)6/2021
Contraindications (4)6/2021
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.6)6/2021

INDICATIONS AND USAGE

Toviaz is indicated for the treatment of:

  • Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1)
  • Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2)

DOSAGE AND ADMINISTRATION

  • OAB in Adults: The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily. (2.1)
  • NDO in Pediatric Patients 6 Years and Older:
    • Pediatric Patients Weighing Greater than 25 kg and up to 35 kg:
      The recommended dosage is 4 mg orally once daily. If needed, dosage may be increased to 8 mg orally once daily. (2.2)
    • Pediatric Patients Weighing Greater than 35 kg:
      The recommended starting dosage is 4 mg orally once daily. After one week, increase to 8 mg orally once daily. (2.2)
  • Adult or Pediatric Patients with Renal Impairment: Refer to the full prescribing information for recommended dosage. (2.3, 2.4)
  • Dosage Modifications Due to Strong CYP3A4 Inhibitors: Refer to the full prescribing information for recommended dosage. (2.5)
  • Administration: Swallow whole with liquid. Do not chew, divide, or crush. Take with or without food. (2.6)

DOSAGE FORMS AND STRENGTHS

Extended-release tablets: 4 mg and 8 mg (3)

CONTRAINDICATIONS

  • Known or suspected hypersensitivity to Toviaz or any of its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. (4)
  • Urinary retention (4)
  • Gastric retention (4)
  • Uncontrolled narrow-angle glaucoma. (4)

WARNINGS AND PRECAUTIONS

  • Angioedema: Promptly discontinue Toviaz and provide appropriate therapy. (5.1)
  • Urinary Retention: Toviaz is not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. (5.2)
  • Decreased Gastrointestinal Motility: Toviaz is not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. (5.3)
  • Worsening of Narrow-Angle Glaucoma: Use Toviaz with caution in patients being treated for narrow-angle glaucoma. (5.4)
  • Central Nervous System Effects: Somnolence has been reported with Toviaz. Advise patients not to drive or operate heavy machinery until they know how Toviaz affects them. (5.5)
  • Worsening of Myasthenia Gravis Symptoms: Use Toviaz with caution in patients with myasthenia gravis. (5.6)

ADVERSE REACTIONS

  • Most frequently reported adverse events with Toviaz in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%; Toviaz 4 mg, 19%; Toviaz 8 mg, 35%) and constipation (placebo, 2%; Toviaz 4 mg, 4%; Toviaz 8 mg, 6%). (6.1)
  • Most frequently reported adverse reactions with Toviaz in pediatric patients (≥2%) with NDO were: diarrhea, urinary tract infection (UTI), dry mouth, constipation, abdominal pain, nausea, weight increased, and headache. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 7/2021

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